Policy & Regulation
Qualigen to begin clinical development of AS1411 for COVID-19 upon FDA's Pre-IND positive response
29 October 2020 -

Biotechnology company Qualigen Therapeutics Inc (Nasdaq:QLGN) said on Wednesday that it has received a positive feedback from the US Food and Drug Administration (FDA) for Type B Pre-IND for the planned clinical development of AS1411 for the treatment of COVID-19.

Following the FDA's positive response, the company plans to reprioritize and first advance AS1411 into clinical trials for treatment of COVID-19 in the first half of calendar 2021, then seek to advance ALAN into clinical trials against acute myeloid leukemia.

According to the company, ALAN (AS1411-GNP) is a DNA coated gold nanoparticle cancer drug candidate that has the potential to target various types of cancer. The foundational aptamer of ALAN, AS1411, is being studied for treating or even preventing viral-based infectious diseases, including COVID-19.

In conjunction, the extensive preclinical research conducted at the University of Louisville has demonstrated that AS1411 has potent anti-viral activity against SARS-CoV-2 infection, the novel coronavirus responsible for COVID-19.

Based on the US FDA's recommendation, the company will evaluate the safety and efficacy of AS1411 in hospitalized patients with COVID-19 in Phase 2a proof-of-concept study, including determining the appropriate dose with outcomes assessed at Day 28.

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